Archives: Agenda

• Selecting the right countries and sites to support global development goals
• Using real-world data and feasibility insights to improve decision-making
• Aligning site selection with recruitment, operational, and regulatory strategies
• Creating scalable site networks for long-term global clinical development success

• 选择合适的国家和中心，以支持全球开发目标。
• 利用真实世界数据和可行性洞察改善决策。
• 将中心选择与招募、运营和法规策略相结合。
• 建立可扩展的中心网络，实现长期全球临床开发成功。

AI is reshaping the entire lifecycle of GLP-1 drug development. This presentation will systematically examine the specific applications of AI technology across the entire R&D chain, covering early-stage molecular design, activity and toxicity prediction, clinical trial design optimization, and optimized scheduling within the clinical supply chain. Using a case study of MindRank’s MAP platform, the session will analyze how AI-driven approaches improve R&D efficiency, reduce costs, and shorten timelines, ultimately advancing a candidate drug into Phase III clinical trials within 4.5 years.

AI正在重塑GLP-1药物的研发全链条。本报告将系统阐述AI技术在药物研发全生命周期中的具体应用，涵盖早期分子设计、活性与毒性预测、临床试验设计优化，以及临床供应端的优化调度。报告将结合德睿智药MAP平台的实际案例，分析如何通过AI驱动的方案提升研发效率、降低成本并缩短周期，并在4.5年内将相关候选药物推进至三期临床试验。

This session outlines an end-to-end framework for Multi-Regional Clinical Trials (MRCTs). It covers critical regional epidemiology and regulatory planning, third-party operational models, the impact of inter-ethnicity differences on future labeling, and navigating health agency registration decisions.

Plan

• Clinical epidemiology in different regions
• Regulatory requirements on protocol design and patient recruitment
• Timeline and financial models

Do

• Operational models involving third parties

Check

• Influence of inter-ethnicity differences and response differences on future label statements

Access

• Agency‘s decision on registration

• The 3+3 design is simple but has limited statistical performance, failing to meet modern Phase I R&D needs.
• BOIN is a model-assisted design whose core centers on constructing optimal decision intervals around the target toxicity rate.
• BOIN combines strong statistical performance with high clinical feasibility.
• Compared to 3+3, BOIN allocates patients more rationally and improves MTD accuracy.
• BOIN has evolved into a design family that extends to efficacy, combination therapies, late-onset toxicities, and OBD optimization.

• 3+3 简单但统计性能有限，已难满足现代 I 期研发需求。
• BOIN 是模型辅助设计，核心是围绕目标毒性率构建最优决策区间。
• BOIN 兼具较强统计性能与较高临床可实施性。
• 相比 3+3，BOIN 能更合理分配患者并提高 MTD 准确率。
• BOIN 已发展为设计家族，可扩展到疗效、联合用药、迟发毒性和 OBD 优化等场景。

• How to build a “Predict and Prevent” Supply Mindset
• Dynamic Re-supply Models for a Dynamic Clinical Reality
• A Step-by-Step Guide to Smoother Cross-Border Movements
• Rapid Response Protocols and Effective Contingency Planning
• Integrating Partners into a Single, Seamless Team

• 如何建立“预测并预防”的供应思维。
• 面向动态临床现实的动态补货模型。
• 更顺畅跨境运输的分步指南。
• 快速响应流程与有效的应急规划。
• 将合作伙伴整合为一个无缝协作团队。

Moderator: Jae-Young Ha, CBO, AriBio

下午茶歇及交流

下午茶歇及交流

• Leveraging China’s integrated research, healthcare, and technology networks to accelerate development
• How scale, speed, and digital innovation are reshaping global clinical trial execution
• Translating local operational excellence into global study success
• Less on drug supplys multinational sponsors can apply from China’s evolving clinical ecosystem

• 借助中国一体化的科研、医疗和技术网络加速开发。
• 规模、速度与数字化创新如何重塑全球临床试验执行。
• 将本土运营卓越转化为全球研究成功。
• 跨国申办方可从中国不断演进的临床生态中借鉴的经验。

Antibody-Drug Conjugates (ADCs) and Bi-Specific Antibodies (BsAbs) represent the cutting edge of targeted oncology therapeutics. The delicate balance of the ADC structure (linker, antibody, payload) and the intricate assembly of the BsAb (two distinct binding domains) impose unprecedented demands for coordination and control across every logistical step, from manufacturing to the patient’s bedside.
抗体偶联药物（ADC）和双特异性抗体（BsAb）代表了靶向肿瘤治疗的前沿。ADC 结构（连接子、抗体、载荷）的精密平衡，以及 BsAb（两个不同结合结构域）的复杂组装，对从产线到病床的每一个物流环节都提出了前所未有的挑战。

• Identifying Critical Vulnerabilities in ADC & BsAb Supply Chains
• Strategies from Point-of-Manufacture to Global Distribution
• How to Leverage IoT and Blockchain for End-to-End Traceability from Factory to Bedside
• Dynamic Strategies for Dose Escalation & Biomarker-Driven Patient Stratification
• Leveraging China’s Mature Biologics Supply Chain Ecosystem

• 识别 ADC 与 BsAb 供应链中的关键节点
• 从生产端到全球配送的策略
• 如何利用 IoT 与区块链实现从产线到病床的端到端可追溯性
• 剂量递增与生物标志物驱动患者分层的动态策略
• 借力中国成熟的生物制品供应链生态